Qualification of cleanrooms
CETEP CANADA performs qualifications (IQ/OQ) upon delivery and periodic quality control (PQ) of manufacturing, research center, and health facility cleanrooms requiring particulate, microbiological, and gas contamination control :
- Verification of compliance with room standards.
- Evaluation of the rooms’ air quality.
- Demonstration of contaminant control.
Tests performed (non-exhaustive list)
- Tightness and filter integrity testing.
- Quality control of discharge air.
- Classification of particles in the environment.
- Measure of discharge and recovery rates.
- Determination of air renewal rates.
- Aerobiocontamination and determination of microbiological classification.
- Surface bioburden.
- Kinetics of particle retention.
- Airflow visualization.
- Measure of temperature and humidity.
- Noise level, brightness level.
- Differential pressure between rooms.
When should these quality controls be carried out ?
- When particle class retention or other parameters are in need of verification.
- After the room has undergone construction or maintenance.
- After HEPA filters have been changed.
CETEP CANADA - quality control, qualification, training, advice and support.